Glaukos Corporation announced it has submitted a new drug application (NDA) to the FDA for its iDose TR, designed to address ubiquitous patient non-compliance and chronic side effects associated with topical glaucoma medications.
Tell me more about the iDose TR.
The iDose TR is a biocompatible titanium implant administered during micro-invasive procedures that contains a novel formulation of travoprost—a prostaglandin analog used to lower intraocular pressure (IOP)—which is released inside the anterior chamber.
By eluting the drug already inside the eye, the device can then bypass the corneal permeability barrier, enabling the release of micro-amounts of travoprost over time.
How long does its effects last?
The implant continuously releases therapeutic medication levels for at least 1 year. Once all the travoprost is released, the implant is removed and could be replaced with another implant.
What did clinical trials show?
Data from two phase 3 pivotal trials both achieved their prespecified primary efficacy endpoints (through three months) as well as a favorable tolerability and safety profile (through 12 months).
Glaukos also used data from an exchange trial—conducted based on an agreement with the FDA to assess the safety and feasibility of exchanging iDose TR implants in patients who had received an iDose TR in a previous phase 2b trial. See those positive findings here.
What’s next?
Now we wait! The FDA has 6 to 10 months to review and determine whether or not to accept the submission.
Significance?
With its ability to be removed and replaced with a new iDose TR, the implant offers the potential of a long-term dropless treatment alternative to daily eye drops.